Physicians prescribe Kaletra in combination with other
medications to treat HIV. The U.S. Food and Drug Administration (FDA) has
approved Kaletra for use by patients aged 14 days and older. Kaletra is two
separate drugs, lopinavir and ritonavir, that belong to a medication class
known as protease inhibitors.

What Does Kaletra Do?

Kaletra works by blocking protease enzymes that are present in
HIV. The lopinavir in the medication works to keep the viruses from
duplicating. The ritonavir in the medication doesn’t act against HIV, but
instead works with the body to maintain steady levels of lopinavir, thus
maximizing that drug’s effectiveness. Kaletra is given as part of combination
drug therapy for HIV. Kaletra is not a cure for HIV or AIDS, but it’s a way to slow HIV’s progression.

What Are the Typical Doses of Kaletra?

The adult dose of Kaletra varies depending on whether the
patient has previously been treated, whether the patient is taking certain
other drugs, and whether the patient has a certain measurement of resistance to
treatment. Patients usually receive special testing before treatment to
determine the best dose.

For patients who have previously had treatment as part of
combination therapy, the adult dose is one tablet (lopinavir 400 milligrams (mg)/ritonavir
100 mg) twice daily with or without food.

For patients who have previously had treatment and who will also
be taking efavirenz (Sustiva), fosamprenavir (Lexiva), nelfinavir (Viracept),
or nevirapine (Viramune), the dose is one tablet (lopinavir 500 mg/ritonavir
125 mg) twice a day or lopinavir 533 mg/ritonavir 133 mg solution twice a
day.

For patients who have previously had treatment and who have less
than three lopinavir resistance associated substitutions, the dose is one
tablet (lopinavir 800 mg/ritonavir 200 mg) once daily.

Once daily dosing is not recommended for patients who are
currently receiving efavirenz, fosamprenavir, nevirapine, nelfinavir,
carbamazeepine, phenobarbital or phenytoin.

Kaletra should be used with caution in patients with liver
disease.

Children aged 14 days to 18 years are dosed according to body
weight or body surface area (BSA). This is calculated using the child’s weight
and height.

Kaletra can be taken with or without food. The oral suspension option should always be
taken with food. The oral suspension also contains alcohol and propylene
glycol, which can increase the risk of adverse effects in premature infants. Infants
are usually 14 days old before treatment with Kaletra is started.

This information is a summary. Before starting this medication,
discuss questions with your healthcare provider and make sure you understand
dosage instructions.

What Should I Tell My Doctor Before
Starting Kaletra?

Tell your doctor before taking Kaletra if you:

What Medications May Interact with
Kaletra?

Always tell your doctor about any prescription medications or
herbal remedies you are taking.Many medications adversely interact with Kaletra, and some
should not be taken with it. Always
review all medications, over-the-counter drugs, and herbal remedies that you
take with your physician and pharmacist before taking Kaletra. Some medications
that can adversely interact with Kaletra include:

Possible Side Effects of Kaletra

Possible Adverse and Emergency Side Effects

The following are severe and emergent side effects of these
medications. Contact your medical provider immediately if you experience:

Possible Nonemergency Side Effects

The following side effects may occur but do not usually
represent an emergency. Discuss them with your doctor or healthcare
professional if they continue or are bothersome. These include:

This list may not describe all possible side effects. Call your
doctor or healthcare provider for advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088.

Kaletra and Pregnancy

The FDA classifies Kaletra in category C, which means the
effects on an unborn baby are unknown. Always notify your doctor if you are
pregnant or thinking of becoming pregnant before taking Kaletra. However,
the Antiretroviral Pregnancy Registry, a large study of pregnant HIV patients
treated with Kaletra, did not find an increase in birth defects in the children
born by these women. Consult your doctor
for the most current recommendation.

Some forms of birth control pills or patches may not work as
well if they are used at the same time as Kaletra. Discuss your birth control
options with your doctor before taking Kaletra.

Kaletra’s manufacturer says that mothers should not breastfeed
while taking Kaletra.

Kaletra and Alcohol

Note that liquid Kaletra contains a small amount of alcohol,
which could interact with disulfiram (Antabuse) to trigger nausea and vomiting.
Patients who must take Kaletra oral suspension should avoid alcohol.

Where Should I Keep Kaletra?

Storage for Kaletra depends upon the type of preparation. Kaletra tablets should be stored at room temperature between
68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius). Oral solutions and
capsules of Kaletra should be stored in a refrigerator between the temperatures
of 36 and 46 degrees Fahrenheit (2 to 8 degrees Celsius). Once opened, the oral
suspension of Kaletra should be used within two months.

Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this medication only
for the indication prescribed.

Important FDA Warnings

FDA WARNING: SERIOUS HEALTH
PROBLEMS THAT HAVE BEEN REPORTED IN PREMATURE BABIES RECEIVING
LOPINAVIR/RITONAVIR (KALETRA) ORAL SOLUTION. LOPINAVIR/RITONAVIR ORAL SOLUTION
CONTAINS THE INGREDIENTS ALCOHOL AND PROPYLENE GLYCOL. PREMATURE BABIES MAY BE
AT INCREASED RISK FOR HEALTH PROBLEMS BECAUSE THEY HAVE A DECREASED ABILITY TO
ELIMINATE PROPYLENE GLYCOL; THIS COULD LEAD TO PROBLEMS
BECAUSE THEY HAVE A DECREASED ABILITY TO ELIMINATE PROPYLENE GLYCOL; THIS COULD
LEAD TO ADVERSE EVENTS SUCH AS SERIOUS HEART, KIDNEY, OR BREATHING PROBLEMS.
BECAUSE THE CONSEQUENCES OF USING LOPINAVIR/RITONAVIR ORAL SOLUTION IN BABIES
IMMEDIATELY AFTER BIRTH CAN BE SEVERE OR POSSIBLY FATAL, THE LABEL has been
REVISED TO INCLUDE A NEW WARNING.

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